FDA Revokes J&J COVID Vaccine Authorization

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FDA Revokes J&J COVID Vaccine Authorization

The Food and Drug Administration has revoked Janssen Biotech’s (J&J) COVID-19 vaccine in the US market.

J&J was one of the three companies making a COVID vaccine for the US, with Pfizer and Moderna being the other two. J&J’s vaccine, however, was the only one of the three that was not an mRNA vaccine, using more traditional methods instead.

Unfortunately for J&J, it’s vaccine never gained the popularity of the other two, despite being a single-shot dose instead of two. There were also some concerns over blood clots in a small percentage of the population that blunted the vaccine’s adoption right as it was beginning to take off.

It seems that J&J is not interested in continuing its efforts in the US, asking the FDA to revoke its authorization. The agency acknowledged receipt of J&J’s request in a letter:

This letter is in response to the request from Janssen Biotech, Inc. received on May 22, 2023, that the U.S. Food and Drug Administration (FDA) withdraw the EUA for the Janssen COVID-19 Vaccine issued on February 27, 2021, as subsequently amended. Janssen Biotech, Inc has informed the FDA that the last lots of the Janssen COVID-19 Vaccine purchased by the United States Government have expired, that there is no demand for new lots of the Janssen COVID-19 Vaccine in the United States, and that Janssen Biotech, Inc does not intend to update the strain composition of this vaccine to address emerging variants.

The agency agreed to withdraw its authorization:

Because FDA understands that Janssen Biotech, Inc. no longer intends to offer the Janssen COVID-19 Vaccine in the United States under the EUA and because Janssen Biotech, Inc. has requested that FDA withdraw the EUA for the Janssen COVID-19 Vaccine, FDA has determined that it is appropriate to protect the public health or safety to revoke this authorization.

Accordingly, FDA hereby revokes EUA 27205 for the Janssen COVID-19 Vaccine, pursuant to section 564(g)(2)(C) of the Act. As of the date of this letter, the Janssen COVID-19 Vaccine is no longer authorized for emergency use by FDA.

FDA Revokes J&J COVID Vaccine Authorization
Staff

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